FDA Grants Breakthrough Designations to Merck's Hepatitis C Candidate

The FDA has granted 2 breakthrough therapy designations to Merck’s chronic hepatitis C virus (HCV) candidate, grazoprevir/elbasvir.

The once-daily, single-tablet regimen originally received breakthrough therapy status for the treatment of chronic HCV genotype 1 (GT1) infection in October 2013. However, the FDA rescinded it in January 2015.

Now, grazoprevir/elbasvir has been fast-tracked for FDA approval in chronic HCV GT1 infection in end-stage renal disease patients on hemodialysis, as well as patients with chronic HCV genotype 4 infection.

“HCV remains a global public health epidemic,” said Eliav Barr, vice president of infectious diseases at Merck Research Laboratories. “At Merck, we are focused on the development of an efficacious, well-tolerated, once-daily therapy that can be used to treat multiple genotypes and a diverse population of chronic HCV patients.”

In addition to being studied in multiple chronic HCV genotypes and HIV co-infection, grazoprevir/elbasvir is undergoing clinical trials in chronic kidney disease, inherited blood disorders, and cirrhosis, as well as subjects taking opiate substitution therapy.

The most common side effects associated with the drug in clinical trials include fatigue, headache, nausea, and diarrhea; however, no participants have dropped out due to adverse effects.